cGMP Facility Mission Statement

The primary mission of the cGMP is to:

1. To act as a resource within the Johns Hopkins Community, providing expertise for the advancement of basic research of human somatic cell and gene therapy into the clinical setting.
   
   
2. Support this translational research with:

   a) in-house immune cell expansion and cell separation
   for phase I and II clinical trials

   b) in-house manufacturing of clinical grade, bio-therapeutics for phase I and II clinical trials

3. To produce these components under current Good Manufacturing Practices (cGMP) as advised by the United States Food and Drug Administration to ensure the safest possible products for our patients.
   
   
4. To foster the growth and development of multidisciplinary clinical trials to combat human diseases.

About GMP Facility

• 1,800 Sq. ft moden design cGMP facility
• Four independently controlled processing suites
• Class 10,000 environment for all the processing suites
• Class 100 Biosafety cabinet for each processing suite
• Separate Gow-In and Gown-Out rooms
• State of art computer monitoring system providing 24-hour alert and data logging for the entire facility and all critical equipment
• In-place decontamination capability

  Major Equipment

• Class 100 Biosafety cabinets
• Liquid nitrogen Freezers, -80C Up right freezers, Planer rate controlled freezers
  
• CO2 incubators, Centrifuges, Sterile welders
• COBE cell concentration & washing unit